U.S. patent number 10,966,829 [Application Number 15/921,005] was granted by the patent office on 2021-04-06 for medical device shaft including a liner.
This patent grant is currently assigned to Boston Scientific Scimed, Inc.. The grantee listed for this patent is BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to Daniel J. Foster, Kevin Robert Poppe, Christopher Jay Scheff, Bradley S. Swehla.
United States Patent |
10,966,829 |
Poppe , et al. |
April 6, 2021 |
Medical device shaft including a liner
Abstract
Medical devices and methods for making and using medical devices
are disclosed. An example delivery system for an implantable
medical device includes an inner shaft having a proximal end
region, a distal end region, a non-circular lumen extending
therethrough. The delivery system also includes a tension
resistance member extending at least partially between the proximal
end region and the distal end region, a deployment catheter
disposed along the outer surface of the shaft, and an actuation
shaft disposed within the non-circular lumen. Further, the
actuation shaft is coupled to the implantable medical device and
translation of the actuation shaft shifts the implantable medical
device from a first position to a second position.
Inventors: |
Poppe; Kevin Robert (New
Brighton, MN), Foster; Daniel J. (Lino Lakes, MN),
Swehla; Bradley S. (Eagan, MN), Scheff; Christopher Jay
(Elk River, MN) |
Applicant: |
Name |
City |
State |
Country |
Type |
BOSTON SCIENTIFIC SCIMED, INC. |
Maple Grove |
MN |
US |
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Assignee: |
Boston Scientific Scimed, Inc.
(Maple Grove, MN)
|
Family
ID: |
1000005467095 |
Appl.
No.: |
15/921,005 |
Filed: |
March 14, 2018 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20180263771 A1 |
Sep 20, 2018 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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62471100 |
Mar 14, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F
2/2436 (20130101); A61F 2/966 (20130101); A61M
25/0032 (20130101); A61M 25/09 (20130101); A61F
2230/0008 (20130101); A61M 25/0147 (20130101); A61F
2230/0017 (20130101); A61M 2025/0004 (20130101); A61M
2025/0037 (20130101); A61M 25/0023 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61F 2/966 (20130101); A61M
25/00 (20060101); A61M 25/01 (20060101); A61M
25/09 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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Jun 1997 |
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May 2013 |
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EP |
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Nov 2012 |
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JP |
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2013524943 |
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Jun 2013 |
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JP |
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5575840 |
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Aug 2014 |
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JP |
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2015501680 |
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Jan 2015 |
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JP |
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2006041612 |
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Apr 2006 |
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WO |
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2006073581 |
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Jul 2006 |
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WO |
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2011133486 |
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Oct 2011 |
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WO |
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Other References
International Search Report and Written Opinion dated Mar. 2, 2018
for International Application No. PCT/US2017/062113. cited by
applicant .
International Search Report and Written Opinion dated May 22, 2018
for International Application No. PCT/US2018/022371. cited by
applicant.
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Primary Examiner: Holwerda; Kathleen S
Assistant Examiner: Labranche; Brooke
Attorney, Agent or Firm: Seager, Tufte & Wickhem LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of priority under 35 U.S.C.
.sctn. 119 to U.S. Provisional Application Ser. No. 62/471,100,
filed Mar. 14, 2017, the entirety of which is incorporated herein
by reference.
Claims
What is claimed is:
1. A delivery system for an implantable medical device, comprising:
an inner shaft having a proximal end region, a distal end region, a
non-circular lumen extending therethrough, and at least one tension
resistance member extending at least partially between the proximal
end region and the distal end region and within the inner shaft; a
first tubular member defining a guidewire lumen; at least one
second tubular member defining an actuation member lumen; a
deployment catheter disposed along an outer surface of the inner
shaft; and an actuation member disposed within the actuation member
lumen; wherein the first tubular member and the at least one second
tubular member are received within the non-circular lumen; wherein
the actuation member is coupled to an implantable medical device;
wherein translation of the actuation member shifts the implantable
medical device from a first position to a second position.
2. The delivery system of claim 1, wherein the implantable medical
device includes an implantable heart valve.
3. The delivery system of claim 1, wherein the inner shaft includes
a second tension resistance member and the at least one tension
resistance member and the second tension resistance member are
disposed along opposite sides of the inner shaft.
4. The delivery system of claim 1, further comprising one or more
additional tubular members, each having an actuation member lumen,
configured to receive an actuation member disposed within the
non-circular lumen, and wherein the non-circular lumen is designed
to limit twisting of tubular members within the non-circular
lumen.
5. The delivery system of claim 1, wherein the inner shaft is
configured to rotate, translate or both rotate and translate
relative to the deployment catheter.
6. The delivery system of claim 1, wherein the non-circular lumen
is designed to limit twisting of the first tubular member and the
at least one second tubular member.
7. The delivery system of claim 1, wherein the at least one tension
resistance member includes a metallic wire.
8. The delivery system of claim 1, wherein the at least one tension
resistance member includes a polymer.
9. A delivery system for an implantable heart valve, comprising: an
inner shaft having a distal end region, a proximal end region, an
ovular lumen extending therethrough, and at least one tension
resistance member extending at least partially between the proximal
end region and the distal end region and within the inner shaft; a
first tubular member defining a guidewire lumen; at least one
second tubular member defining an actuation member lumen; a
deployment catheter disposed along an outer surface of the inner
shaft; and an actuation member disposed within the actuation member
lumen; wherein the first tubular member and the at least one second
tubular member are received within the ovular lumen; wherein the
actuation member is configured to be coupled to an implantable
heart valve; wherein translation of the actuation member shifts the
implantable heart valve from a first position to a second
position.
10. The delivery system of claim 9, wherein the inner shaft
includes a second tension resistance member and the at least one
tension resistance member and the second tension resistance member
are disposed along opposite sides of the inner shaft.
11. The delivery system of claim 9, further comprising one or more
additional tubular members, each having an actuation member lumen,
configured to receive an actuation member disposed within the
ovular lumen, and wherein the ovular lumen is designed to limit
twisting of tubular members within the ovular lumen.
12. The delivery system of claim 9, wherein the ovular lumen is
designed to limit twisting of the first tubular member and the at
least one second tubular member.
13. The delivery system of claim 9, wherein the at least one
tension resistance member includes a metallic wire.
14. The delivery system of claim 9, wherein the at least one
tension resistance member includes a polymer.
Description
TECHNICAL FIELD
The present disclosure pertains to medical devices, and methods for
manufacturing medical devices. More particularly, the present
disclosure pertains to medical devices including a reduced profile
inner liner.
BACKGROUND
A wide variety of intracorporeal medical devices have been
developed for medical use, for example, intravascular use. Some of
these devices include guidewires, catheters, and the like. These
devices are manufactured by any one of a variety of different
manufacturing methods and may be used according to any one of a
variety of methods. Of the known medical devices and methods, each
has certain advantages and disadvantages. There is an ongoing need
to provide alternative medical devices as well as alternative
methods for manufacturing and using medical devices.
BRIEF SUMMARY
This disclosure provides design, material, manufacturing method,
and use alternatives for medical devices. An example delivery
system for an implantable medical device includes an inner shaft
having a proximal end region, a distal end region, a non-circular
lumen extending therethrough. The delivery system also includes a
tension resistance member extending at least partially between the
proximal end region and the distal end region, a deployment
catheter disposed along the outer surface of the shaft, and an
actuation shaft disposed within the non-circular lumen. Further,
the actuation shaft is coupled to the implantable medical device
and translation of the actuation shaft shifts the implantable
medical device from a first position to a second position.
Alternatively or additionally to any of the embodiments above,
wherein the implantable medical device includes an implantable
heart valve.
Alternatively or additionally to any of the embodiments above,
wherein the inner shaft includes a pair of tension resistance
members disposed along opposite sides of the inner shaft.
Alternatively or additionally to any of the embodiments above,
further comprising a pair of actuation shafts disposed within the
non-circular lumen, and wherein the non-circular lumen is designed
to limit twisting of the actuation shafts within the lumen.
Alternatively or additionally to any of the embodiments above,
wherein the inner shaft is configured to rotate, translate or both
rotate and translate relative to the deployment catheter.
Alternatively or additionally to any of the embodiments above,
further comprising a first tubular member extending within the
non-circular lumen, and wherein the first tubular member is
designed to accept a guidewire extending therein.
Alternatively or additionally to any of the embodiments above,
further comprising a second tubular member extending within the
non-circular lumen, and wherein actuation shaft extends within the
second tubular member.
Alternatively or additionally to any of the embodiments above,
wherein the non-circular lumen is designed to limit twisting of the
first tubular member and the second tubular member.
Alternatively or additionally to any of the embodiments above,
wherein the tension resistance member includes a metallic wire.
Alternatively or additionally to any of the embodiments above,
wherein the tension resistance member includes a polymer.
Another example delivery system for an implantable heart valve,
comprising: an inner shaft having a distal end region, an ovular
lumen extending therethrough, and a tension resistance member
extending at least partially between the proximal end region and
the distal end region; a deployment catheter disposed along the
outer surface of the shaft; and an actuation shaft disposed within
the ovular lumen; wherein the actuation shaft is coupled to the
implantable medical device; wherein translation of the actuation
shaft shifts the heart valve from a first position to a second
position.
Alternatively or additionally to any of the embodiments above,
wherein the inner shaft includes a pair of tension resistance
members disposed along opposite sides of the inner shaft.
Alternatively or additionally to any of the embodiments above,
further comprising a pair of actuation shafts disposed within the
ovular lumen, and wherein the ovular lumen is designed to limit
twisting of the actuation shafts within the ovular lumen.
Alternatively or additionally to any of the embodiments above,
further comprising a first tubular member extending within the
ovular lumen, and wherein the first tubular member is designed to
accept a guidewire extending therein.
Alternatively or additionally to any of the embodiments above,
further comprising a second tubular member extending within the
ovular lumen, and wherein actuation shaft extends within the second
tubular member.
Alternatively or additionally to any of the embodiments above,
wherein the ovular lumen is designed to limit twisting of the first
tubular member and the second tubular member.
Alternatively or additionally to any of the embodiments above,
wherein the tension resistance member includes a metallic wire.
Alternatively or additionally to any of the embodiments above,
wherein the tension resistance member includes a polymer.
A method for delivering an implantable medical device, the system
comprising: advancing a medical device delivery system to a target
site in the heart, the medical device delivery system including: an
inner shaft having a proximal end region, a distal end region, a
non-circular lumen extending therethrough, and a tension resistance
member extending at least partially between the proximal end region
and the distal end region; a deployment catheter disposed along the
outer surface of the shaft; an actuation shaft disposed within the
non-circular lumen; and an implantable heart valve coupled to the
actuation shaft; retracting the deployment catheter relative to the
inner shaft; translating the actuation shaft relative to the inner
shaft, wherein translating the actuation shaft shifts the
implantable medical device from a collapsed position to a deployed
position.
Alternatively or additionally to any of the embodiments above,
wherein the implantable medical device includes an implantable
heart valve.
The above summary of some embodiments is not intended to describe
each disclosed embodiment or every implementation of the present
disclosure. The Figures, and Detailed Description, which follow,
more particularly exemplify these embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
The disclosure may be more completely understood in consideration
of the following detailed description in connection with the
accompanying drawings, in which:
FIG. 1 is a side view of an example medical device system;
FIG. 2 is a perspective view of a portion of the shaft of the
medical device shown in FIG. 1;
FIG. 3 is a perspective view of an example inner catheter of the
medical device system shown in FIG. 1 and FIG. 2;
FIG. 4 is a perspective view of another example inner catheter of
the medical device system shown in FIG. 1 and FIG. 2;
FIG. 5 is a cross-sectional view of the example inner catheter of
the medical device system shown in FIG. 4.
While the disclosure is amenable to various modifications and
alternative forms, specifics thereof have been shown by way of
example in the drawings and will be described in detail. It should
be understood, however, that the intention is not to limit the
disclosure to the particular embodiments described. On the
contrary, the intention is to cover all modifications, equivalents,
and alternatives falling within the spirit and scope of the
disclosure.
DETAILED DESCRIPTION
For the following defined terms, these definitions shall be
applied, unless a different definition is given in the claims or
elsewhere in this specification.
All numeric values are herein assumed to be modified by the term
"about", whether or not explicitly indicated. The term "about"
generally refers to a range of numbers that one of skill in the art
would consider equivalent to the recited value (e.g., having the
same function or result). In many instances, the terms "about" may
include numbers that are rounded to the nearest significant
figure.
The recitation of numerical ranges by endpoints includes all
numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3,
3.80, 4, and 5).
As used in this specification and the appended claims, the singular
forms "a", "an", and "the" include plural referents unless the
content clearly dictates otherwise. As used in this specification
and the appended claims, the term "or" is generally employed in its
sense including "and/or" unless the content clearly dictates
otherwise.
It is noted that references in the specification to "an
embodiment", "some embodiments", "other embodiments", etc.,
indicate that the embodiment described may include one or more
particular features, structures, and/or characteristics. However,
such recitations do not necessarily mean that all embodiments
include the particular features, structures, and/or
characteristics. Additionally, when particular features,
structures, and/or characteristics are described in connection with
one embodiment, it should be understood that such features,
structures, and/or characteristics may also be used connection with
other embodiments whether or not explicitly described unless
clearly stated to the contrary.
The following detailed description should be read with reference to
the drawings in which similar elements in different drawings are
numbered the same. The drawings, which are not necessarily to
scale, depict illustrative embodiments and are not intended to
limit the scope of the invention.
Diseases and/or medical conditions that impact the cardiovascular
system are prevalent throughout the world. Traditionally, treatment
of the cardiovascular system was often conducted by directly
accessing the impacted part of the system. For example, treatment
of a blockage in one or more of the coronary arteries was
traditionally treated using coronary artery bypass surgery. As can
be readily appreciated, such therapies are rather invasive to the
patient and require significant recovery times and/or treatments.
More recently, less invasive therapies have been developed, for
example, where a blocked coronary artery could be accessed and
treated via a percutaneous catheter (e.g., angioplasty). Such
therapies have gained wide acceptance among patients and
clinicians.
Some relatively common medical conditions may include or be the
result of inefficiency, ineffectiveness, or complete failure of one
or more of the valves within the heart. For example, failure of the
aortic valve or the mitral valve can have a serious effect on a
human and could lead to serious health condition and/or death if
not dealt with properly. Treatment of defective heart valves poses
other challenges in that the treatment often requires the repair or
outright replacement of the defective valve. Such therapies may be
highly invasive to the patient. Disclosed herein are medical
devices that may be used for delivering a medical device to a
portion of the cardiovascular system in order to diagnose, treat,
and/or repair the system. At least some of the medical devices
disclosed herein may be used to deliver and implant a replacement
heart valve (e.g., a replacement aortic valve, replacement mitral
valve, etc.). In addition, the devices disclosed herein may deliver
the replacement heart valve percutaneously and, thus, may be much
less invasive to the patient. The devices disclosed herein may also
provide a number of additional desirable features and benefits as
described in more detail below.
The figures illustrate selected components and/or arrangements of a
medical device system 10, shown schematically in FIG. 1 for
example. It should be noted that in any given figure, some features
of the medical device system 10 may not be shown, or may be shown
schematically, for simplicity. Additional details regarding some of
the components of the medical device system 10 may be illustrated
in other figures in greater detail. A medical device system 10 may
be used to deliver and/or deploy a variety of medical devices to a
number of locations within the anatomy. In at least some
embodiments, the medical device system 10 may include a replacement
heart valve delivery system (e.g., a replacement aortic valve
delivery system) that can be used for percutaneous delivery of a
medical implant 16, such as a replacement/prosthetic heart valve.
This, however, is not intended to be limiting as the medical device
system 10 may also be used for other interventions including valve
repair, valvuloplasty, delivery of an implantable medical device
(e.g., such as a stent, graft, etc.), and the like, or other
similar interventions.
The medical device system 10 may generally be described as a
catheter system that includes an outer sheath 12, an inner catheter
14 (a portion of which is shown in FIG. 1 in phantom line)
extending at least partially through a lumen of the outer sheath
12, and a medical implant 16 (e.g., a replacement heart valve
implant) which may be coupled to the inner catheter 14 and disposed
within a lumen of the outer sheath 12 during delivery of the
medical implant 16. In some embodiments, a medical device handle 18
may be disposed at a proximal end of the outer sheath 12 and/or the
inner catheter 14 and may include one or more actuation mechanisms
associated therewith. In other words, a tubular member (e.g., the
outer sheath 12, the inner catheter 14, etc.) may extend distally
from the medical device handle 18. In general, the medical device
handle 18 may be designed to manipulate the position of the outer
sheath 12 relative to the inner catheter 14 and/or aid in the
deployment of the medical implant 16.
In use, the medical device system 10 may be advanced percutaneously
through the vasculature to a position adjacent to an area of
interest and/or a treatment location. For example, in some
embodiments, the medical device system 10 may be advanced through
the vasculature to a position adjacent to a defective native valve
(e.g., aortic valve, mitral valve, etc.). Alternative approaches to
treat a defective aortic valve and/or other heart valve(s) are also
contemplated with the medical device system 10. During delivery,
the medical implant 16 may be generally disposed in an elongated
and low profile "delivery" configuration within the lumen and/or a
distal end of the outer sheath 12, as seen schematically in FIG. 1
for example. Once positioned, the outer sheath 12 may be retracted
relative to the medical implant 16 and/or the inner catheter 14 to
expose the medical implant 16. In some instances, the medical
implant 16 may be self-expanding such that exposure of the medical
implant 16 may deploy the medical implant 16. Alternatively, the
medical implant 16 may be expanded/deployed using the medical
device handle 18 in order to translate the medical implant 16 into
a generally shortened and larger profile "deployed" configuration
suitable for implantation within the anatomy. For example, in some
instances the inner catheter (or components thereof) may be coupled
to medical implant 16 whereby actuation of the inner catheter 14
relative to the outer sheath 12 and/or the medical implant 16 may
deploy the medical device 16 within the anatomy. When the medical
implant 16 is suitably deployed within the anatomy, the medical
device system 10 may be disconnected, detached, and/or released
from the medical implant 16 and the medical device system 10 can be
removed from the vasculature, leaving the medical implant 16 in
place in a "released" configuration.
It can be appreciated that during delivery and/or deployment of an
implantable medical device (e.g., the medical implant 16), portions
of the medical device system 10 may be required to be advanced
through tortuous and/or narrow body lumens. Therefore, it may be
desirable to utilize components and design medical delivery systems
(e.g., such as the medical device system 10 and/or other medical
devices) that reduce the profile of portions of the medical device
while maintaining sufficient strength (compressive, torsional,
etc.) and flexibility of the system as a whole.
FIG. 2 illustrates a portion of an example shaft 20 that may that
reduce the profile of portions of the medical device while
maintaining sufficient strength (compressive, torsional, etc.) and
flexibility of the system as a whole. In some instances, the shaft
20 may be used as the inner catheter 14 in the medical device
system 10 illustrated in FIG. 1. However, the shaft 20 may be other
components of the medical device system 10, a component of a
different medical device system (e.g., a stent delivery system, an
angioplasty system, a biopsy system, etc.), any other medical
device where reduced profile designs may be required, or the
like.
The shaft 20 may include an inner member or the liner 22. The inner
liner 22 may include a number of features as discussed herein. An
outer member 28 may be disposed along the outer surface of the
inner liner 22. The outer member 28 may be designed to translate
and/or rotate relative to the liner 22. For example, it can be
appreciated that as the shaft 20 is advanced through the anatomy,
the liner 22 may translate longitudinally or radially twist within
the outer member 28.
The inner liner 22 may include a number of features. For example,
the inner liner 22 may include one or more tension resistance
members 30a/30b. The tension resistance members 30a/30b may take
the form of a wire (e.g., a metallic wire), a braid, cable,
stranded cable, a composite structure, or the like. In one example,
the tension resistance members 30a/30b are both metallic wires. In
another instance, the tension resistance members 30a/30b are both
metallic braids. The braids may further includes an axial wire made
from a suitable polymer or metal (e.g., aramid). The tension
resistance members 30a/30b may be made from the same materials
and/or have the same configuration. Alternatively, the tension
resistance members 30a/30b may be different from one another.
Furthermore, while FIG. 2 illustrates that the inner liner 22
includes two tension resistance members 30a/30b, this is not
intended to be limiting. Other numbers of tension resistance
members 30a/30b are contemplated such as one, three, four, five,
six, seven, or more.
The inner liner 22 may also include a lumen 32. In some instances,
a first tubular member 34 may be disposed within the lumen 32. The
first tubular member 34 may define a guidewire lumen 35, through
which a guidewire 36 may extend. A second tubular member 38 may
also be disposed within the lumen 32. The second tubular member 38
may define a lumen 39 through which an actuation member 40 may
extend. As described above, the actuation member 40 may be coupled
and/or attached to the medical implant 16. Translation of the
actuation member 40 may shift the implant 16 from a first collapsed
configuration to a second deployed configuration.
FIG. 3 illustrates the liner 22 described with respect to FIGS.
1-2. As shown in FIG. 3 and described above, the liner 22 may
include a pair of tension resistance members 30a/30b which are
positioned on opposite sides of the lumen 32. FIG. 3 further
illustrates that the shape of the lumen 32 may be designed to limit
twisting of the first tubular member 34 and the second tubular
member 38 relative to one another. For example, FIG. 3 illustrates
that the lumen 32 may be non-circular. For example, the shape of
the lumen 32 may be ovular, square, rectangular, triangular,
combinations thereof, etc. These are just examples. The inner liner
22 may vary in form. For example, the inner liner 22 may include
various shapes in combination with a single lumen or multiple
lumens. Further, the liner 22 may lack a lumen.
It can be appreciated that as the liner 22 rotates within the lumen
of the outer member 28, the non-circular shape of the lumen 32 may
force both the first tubular member 34 and the second tubular
member 38 to maintain their respective spatial relationship as
depicted in FIG. 2. In other words, the shape of the lumen 32
forces the first tubular member 34 and the second tubular member 38
to remain in their respective positions relative to one another
independent of the bending, rotating, flexing, etc. of the liner
22.
While FIG. 2 illustrates that the lumen 32 is designed to
accommodate a first tubular member 34 and a second tubular member
38, it is contemplated that the lumen 32 may be configured to
accommodate more or less than two individual tubular members. For
example, the lumen 32 may be shaped to accommodate one, two, three,
four, five, six, seven, eight or more lumens. Further, it is
contemplated that the particular shape of the lumen 32 may be
designed to match the outer profile of any number of lumens
collectively grouped together. For example, while not depicted in
the figures, it can be appreciated that a triangular-shaped lumen
32 may match the outer profile of three circular tubular members
grouped together at approximately 120 degrees offset from one
another. This is not intended to be limiting. Rather, the lumen 32
may be shaped to match the profile of any collection of tubular
members having any given outer profile. As discussed above,
matching the shape of the lumen 32 with the profile of the tubular
members positioned therein limits the ability of the tubular
members from twisting around one another within the lumen 32.
It can be further appreciated that varying the shape of the lumen
32 may contribute to reducing the overall profile of the liner 22,
and by extension, the overall profile of the shaft 20. For example,
varying the shape of the lumen 32 may permit the reduction in the
wall thickness separating individual lumens extending within the
liner 22. Reducing the wall thickness separating the individual
lumens may permit the overall profile of the liner 22 and/or the
shaft 20 to be much smaller than existing liners/shaft designs.
Additionally, it can be appreciated that it may be desirable to
vary the shape of the profile of the outer surface of liner 22. For
example, FIG. 4 illustrates another example liner 122. Liner 122
may be similar in form and function to other liners discussed
herein. For example, liner 122 may include an inner lumen 132 and
two tension resistance members 130a/130b. However, as shown in FIG.
4, liner 122 may also an outer surface profile that includes one or
more longitudinally extending channels 121 (e.g., grooves, troughs,
etc.) extending along the length thereof. As shown in FIG. 4, each
of the channels 121 may include a curved portion that, in some
examples, follows the profile of the inner lumen 132 and two
tension resistance members 130a/130b.
FIG. 5 illustrates a cross-sectional view of the inner liner 122
shown in FIG. 4. However, FIG. 5 further illustrates an outer
member 128 (which may be similar in form and function to outer
member 28 discussed above) positioned over the inner liner 122. It
can be appreciated from FIG. 5 that one or more of the channels 121
may create one or more "pseudo-lumens" (e.g., space, opening,
aperture, etc.) extending the length of liner 122 and outer member
128 between the outer surface of inner liner 122 and the inner
surface of outer member 128. In some instances, it may be desirable
to extend (e.g., position) wires, cables, etc. through the channels
121. It is contemplated that the wires, cables, etc. which may be
extended through channels 121 may be in addition to the two tension
resistance members 130a/130b.
The materials that can be used for the various components of the
medical devices and/or systems disclosed herein (e.g., shaft 20
and/or other shafts disclosed herein) may include those commonly
associated with medical devices. For simplicity purposes, the
following discussion makes reference to the shaft 20. However, this
is not intended to limit the devices and methods described herein,
as the discussion may be applied to other shafts and/or components
of the medical devices and/or systems disclosed herein including
the various bead members, barrel members, etc.
The shaft 20 may be made from a metal, metal alloy, polymer (some
examples of which are disclosed below), a metal-polymer composite,
ceramics, combinations thereof, and the like, or other suitable
material. Some examples of suitable polymers may include
polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene
(ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene
(POM, for example, DELRIN.RTM. available from DuPont), polyether
block ester, polyurethane (for example, Polyurethane 85A),
polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for
example, ARNITEL.RTM. available from DSM Engineering Plastics),
ether or ester based copolymers (for example,
butylene/poly(alkylene ether) phthalate and/or other polyester
elastomers such as HYTREL.RTM. available from DuPont), polyamide
(for example, DURETHAN.RTM. available from Bayer or CRISTAMID.RTM.
available from Elf Atochem), elastomeric polyamides, block
polyamide/ethers, polyether block amide (PEBA, for example
available under the trade name PEBAX.RTM.), ethylene vinyl acetate
copolymers (EVA), silicones, polyethylene (PE), high density
polyethylene (HDPE), polyester, Marlex high-density polyethylene,
Marlex low-density polyethylene, linear low density polyethylene
(for example REXELL.RTM.), ultra-high molecular weight (UHMW)
polyethylene, polypropylene, polybutylene terephthalate (PBT),
polyethylene terephthalate (PET), polytrimethylene terephthalate,
polyethylene naphthalate (PEN), polyetheretherketone (PEEK),
polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS),
polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for
example, KEVLAR.RTM.), polysulfone, nylon, nylon-12 (such as
GRILAMID.RTM. available from EMS American Grilon), perfluoro(propyl
vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin,
polystyrene, epoxy, polyvinylidene chloride (PVdC),
poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or
SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other
suitable materials, or mixtures, combinations, copolymers thereof,
polymer/metal composites, and the like. In some embodiments the
sheath can be blended with a liquid crystal polymer (LCP).
Some examples of suitable metals and metal alloys include stainless
steel, such as 304V, 304L, and 316LV stainless steel; mild steel;
nickel-titanium alloy such as linear-elastic and/or super-elastic
nitinol; other nickel alloys such as nickel-chromium-molybdenum
alloys (e.g., UNS: N06625 such as INCONEL.RTM. 625, UNS: N06022
such as HASTELLOY.RTM. C-22.RTM., UNS: N10276 such as
HASTELLOY.RTM. C276.RTM., other HASTELLOY.RTM. alloys, and the
like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL.RTM.
400, NICKELVAC.RTM. 400, NICORROS.RTM. 400, and the like),
nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as
MP35-N.RTM. and the like), nickel-molybdenum alloys (e.g., UNS:
N10665 such as HASTELLOY.RTM. ALLOY B2.RTM.), other nickel-chromium
alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys,
other nickel-iron alloys, other nickel-copper alloys, other
nickel-tungsten or tungsten alloys, and the like; cobalt-chromium
alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such
as ELGILOY.RTM., PHYNOX.RTM., and the like); platinum enriched
stainless steel; titanium; combinations thereof; and the like; or
any other suitable material.
In at least some embodiments, portions or all of the shaft may also
be doped with, made of, or otherwise include a radiopaque material.
Radiopaque materials are understood to be materials capable of
producing a relatively bright image on a fluoroscopy screen or
another imaging technique during a medical procedure. This
relatively bright image aids the user of the shaft in determining
its location. Some examples of radiopaque materials can include,
but are not limited to, gold, platinum, palladium, tantalum,
tungsten alloy, polymer material loaded with a radiopaque filler,
and the like. Additionally, other radiopaque marker bands and/or
coils may also be incorporated into the design of the shaft 20 to
achieve the same result.
In some embodiments, a degree of Magnetic Resonance Imaging (Mill)
compatibility is imparted into the shaft. For example, the shaft 20
may include a material that does not substantially distort the
image and create substantial artifacts (e.g., gaps in the image).
Certain ferromagnetic materials, for example, may not be suitable
because they may create artifacts in an MRI image. The shaft 20 may
also be made from a material that the MM machine can image. Some
materials that exhibit these characteristics include, for example,
tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such
as ELGILOY.RTM., PHYNOX.RTM., and the like),
nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as
MP35-N.RTM. and the like), nitinol, and the like, and others.
It should be understood that this disclosure is, in many respects,
only illustrative. Changes may be made in details, particularly in
matters of shape, size, and arrangement of steps without exceeding
the scope of the disclosure. This may include, to the extent that
it is appropriate, the use of any of the features of one example
embodiment being used in other embodiments. The disclosure's scope
is, of course, defined in the language in which the appended claims
are expressed.
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